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Co-ordinates and prepares document packages for regulatory submissions from all areas of the organization. Collects all materials required in submissions, license renewal, and annual registrations. Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies. Works on problems of complex scope where data analysis requires evaluation of specific factors. Utilizes independent judgment within broad parameters to determine an appropriate solution.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and no experience.

Job Description

Evaluate complaints to determine if MDR/MDV reports are required to FDA and Competent Authorities. 

Review reports of customer complaints and assess them for MDR / MDV reportability to FDA / Competent Authorities

Ensure initial and follow up reports are submitted to Regulatory Agencies within required timelines.

Partner with Quality Complaint-Handling personnel to assure the complaint records contain all required information to make a compliant regulatory decision.

Support interactions with Regulatory Agencies as required.

May aid in updating current procedures/processes or assist in creating new procedures/processes.

Review and analyze data for trending purposes

Work from verbal and/or written instructions.

Track metrics on process timeliness and effectiveness.

Participate in Post-Market Compliance initiatives.

1 to 3 years of experience as a Regulatory or Quality professional in a regulated manufacturing environment, preferably Medical Devices. 

Experience with MDR/MDV reporting preferred.

Ideal candidate will demonstrate applied knowledge of US and International Medical Device Regulations and Standards including but not limited to: FDA: CFR 21 Part 803 (MDR), and CFR 21 Part 820 (QSR), MEDDEV 2.12-1 (Guidelines on Medical Device Vigilance System), ISO 13485 (International Organization for Standardization), etc.

Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development and Marketing and Quality. 

Demonstrated problem-solving and troubleshooting skills.

Demonstrated ability to exhibit a positive, energetic approach to teamwork.

Proficient with Microsoft Office and ability to learn Corporate systems

Demonstrate interpersonal, written English and oral communication skills

Ability to interface with both technical and non-technical personnel at all organizational levels.

Ability to read and interpret Engineering schematics / drawings / prints

Demonstrate organizational, problem-solving, and analytical and time management skills

Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines

Knowledge of manufacturing processes and demonstrated ability to advocate product excellence and quality.

Demonstrate results orientation and ability to learn quickly.

Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.